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Pravin U Dugel, James Warburton, Andreas Weichselberger, Peter Sallstig; A 2-year study comparing the efficacy and safety of brolucizumab vs aflibercept in subjects with neovascular age-related macular degeneration: testing an alternative treatment regimen. Invest. Ophthalmol. Vis. Sci. 2016;57(12):5018.
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Brolucizumab is a first-in-kind single chain anti-VEGF antibody fragment evaluated for the treatment of neovascular age-related macular degeneration (nAMD). Results from 2 previous Phase I/II studies support that brolucizumab has potentially greater duration of effect compared with existing anti-VEGF treatments. These studies provided the basis for the ongoing Phase III (HAWK) study.
HAWK (NCT02307682) is a 2-year, randomized, double-masked, multicenter, 3-arm (1:1:1 randomization) study comparing the efficacy and safety of brolucizumab vs aflibercept in subjects with nAMD. Based on results and additional analysis from previous studies, the HAWK study assesses an alternative treatment regimen, which utilizes the potential for longer duration of effect. As an alternative to treat and extend, patients in the brolucizumab arm who meet prespecified criteria will be treated on a q12-week interval directly after the loading phase with the option for a q8-week interval in case of disease activity. Brolucizumab 3 mg (arm 1) and 6 mg (arm 2) will be initially injected 3 times on a q4-week interval, followed by q12-week injections up to week 92 unless disease activity is identified. In arm 3, aflibercept 2 mg will be injected 3 times on a q4-week interval followed by q8-week injections up to week 92, according to label.
Primary efficacy endpoint is change in best-corrected visual acuity (BCVA) from baseline to week 48. Key secondary endpoints are average change in BCVA from baseline for weeks 36-48 and q12-week treatment status at week 48 (arms 1 and 2 only). Additional efficacy endpoints include change in CSFT from baseline to each postbaseline visit, and absence of subretinal fluid and intraretinal fluid at each postbaseline visit. Following the loading phase, subjects will be evaluated twice for disease activity in the first ‘learning’ q12-week cycle and once after each subsequent q12-week cycle. If disease activity is identified, the subjects will be reassigned to receive q8-week injections thereafter, up to study exit.
The alternative treatment regimen of the HAWK study allows an evaluation of the potential of brolucizumab for q12-week dosing. Brolucizumab has the potential to address a significant unmet need in the treatment of patients with nAMD by reducing treatment burden.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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